Theraclion SA

Earnings Release • Jul 31, 2023

THERACLION EXECUTES STRATEGY IN FIRST HALF

Malakoff, July 31st, 2023, at 06:30pm - THERACLION (ISIN: FR0010120402; Mnemo: ALTHE), an innovative company developing a scalable robotic platform for non-invasive ultrasound therapy, presents its review of the first half of 2023, marked by the achievement of milestones in the deployment of its strategy and the growth of its sales.

Roadmap implementation

In the first half of 2023, Theraclion appointed its new CEO, Martin Deterre, signed a partnership with Furui and secured the necessary funding for the next two years. Theraclion has reached important milestones in the 3 axes of its strategy focused on the treatment of varicose veins:

• Access to the U.S. market: the success of its feasibility study and the FDA's authorization to launch the pivotal multicenter study;
• Access to the Chinese market: the signing in late May of a partnership agreement with Furui to accelerate market access;
• On technological and robotic innovation: significant progress on system development, notably with a view to adding artificial intelligence.

US pivotal study to be launched by the end of the year

Earlier this year, Theraclion announced the success of its U.S. feasibility study, with final results showing a 100% feasibility rate - the trial's primary endpoint - and suppression of venous reflux in 95% of cases. Accelerating its path to the U.S. market, Theraclion recently obtained FDA approval for the launch of the pivotal multi-center study, which will be conducted at four centers recognized for their scientific excellence in the U.S. and Europe. The principal investigator, Steven Elias, MD, Director of the Center for Vein Disease at a prestigious hospital in New Jersey, is a member of the American Board of Venous and Lymphatic Medicine and the American College of Surgeons.

A strategic partnership with Furui to access the Chinese market

A Theraclion SA shareholder since 2016 and co-shareholder of Theraclion China, Furui invested €6 million in the June capital increase of €8.4 million. Its investment will be topped up by a further 1 million euros subject to Theraclion achieving operational targets. Furui and Theraclion also join forces to conquer the Chinese market. Theraclion will license its technologies and the use of its trademarks to Theraclion China, for a 3 million euros fee, to be paid on achievement of milestones.

R&D is the pillar of value creation

Successive improvements will be made to the system over the next few years, notably in robotics and artificial intelligence. Combining its real-time imaging and robotics capabilities, AI algorithms will automate certain tasks, speed up the procedure, and drastically simplify interactions between the doctor and SONOVEIN®.

Partnerships with a dozen reference centers in Europe are continuing, contributing to the accelerated advancement of the technology.

First-half 2023 sales up 183%

Theraclion SA reported sales of €981 K for the first half of 2023, an increase of 183% compared with the first half of 2022. Theraclion is also maintaining strict control over its expenses.

System sales, at €597 K, were up 469%. Theraclion sold a latest-generation device to the University of Virginia as part of a clinical trial on breast cancer research. Approved by the FDA, this pilot study aims to evaluate the combined effects of high-intensity focused ultrasound (HIFU) and low-dose chemotherapy on the immune response in patients with early-stage breast cancer.

Additional revenues on previous sales were also recorded.

Sales of consumables rose by 65%, driven by a doubling of sales in the varicose vein indication. Theraclion has chosen to make SONOVEIN® available to reference centers for the development of treatment protocols. These centers have the option of using SONOVEIN® in their commercial practice, which generates revenue for Theraclion.

In summary, Martin Deterre, Chief Executive Officer of Theraclion, said, "Theraclion is intensifying its efforts on its clearly defined strategy: focusing its forces on the U.S. clinical study, building its partnership with Furui in China, and deploying transformative technological improvements for physicians and patients."

Sales /K€	S1 2023	S1 2022	Variation
System sales	597	105	+469%
Consumable sales	314	190	+65%
Service sales	69	52	+33%
Theraclion SA Sales	981	347	+183%
Including veins	435	135	+222%
Including breast and thyroid	546	212	+157%

About Theraclion

Theraclion is a French MedTech company committed to developing a non-invasive alternative to surgery through the innovative use of focused ultrasound.

High Intensity Focused Ultrasound (HIFU) does not require incisions nor an operating room, leaves no scars, and allows patients an immediate return to their daily activities. Echotherapy, as the HIFU treatment method is called, concentrates therapeutic ultrasounds to an internal focal point from outside of the body.

Theraclion has developed two CE-marked robotic platforms delivering echotherapy: SONOVEIN® for varicose veins and ECHOPULSE® for breast fibroadenoma and thyroid nodules. Each representing the potential to replace millions of surgical procedures every year.

Based in Malakoff (Paris), the Theraclion team is made up of 30 people, mainly in technological and clinical development.

For more information, please visit www.theraclion.com or www.echotherapy.com and follow the account on LinkedIn.

Theraclion is listed on Euronext Growth Paris Eligible for the PEA-PME scheme Mnemonic: ALTHE - ISIN code: FR0010120402 LEI: 9695007X7HA7A1GCYD29

Theraclion contact

Martin Deterre Chief Executive Officer contact@theraclion.com